Standard Operating Procedure for Use of Activated Carbon in Recovery Process in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/051/2025 |
| Supersedes | SOP/API/051/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a standardized procedure for the use of activated carbon during the recovery of solvents in API manufacturing, ensuring the removal of organic impurities, color bodies, and odor-causing compounds, while maintaining product integrity and GMP compliance.
2. Scope
This SOP applies to all solvent recovery processes where activated carbon is used to treat contaminated or discolored solvents before distillation or reuse within the API manufacturing unit.
3. Responsibilities
- Production Operator: Handle and dose activated carbon as per batch instructions.
- Shift Supervisor: Monitor carbon treatment parameters and document usage.
- QA Department: Approve carbon usage and review records for compliance.
- QC Department: Perform quality testing of solvents post carbon treatment.
4. Accountability
The Production Manager is accountable for execution of this procedure. QA Manager is accountable for ensuring adherence to quality and regulatory guidelines.
5. Procedure
5.1 Selection and Verification
- Use only pharmaceutical-grade activated carbon approved by QC.
- Check for:
- Certificate of Analysis (CoA)
- Mesh size and adsorption efficiency
- Expiry date and batch number
5.2 Charging Activated Carbon
- Ensure solvent holding tank or treatment vessel is clean and dry.
- Calculate required quantity of activated carbon based on:
- Solvent type and volume
- Contamination level (typically 0.2–1.0% w/v)
- Slowly add activated carbon under stirring using PPE and dust mask to avoid inhalation.
- Maintain agitation for 30 to 90 minutes depending on the impurity profile.
5.3 Filtration and Collection
- After treatment, filter the carbon-treated solvent through sparkler or Nutsche filter.
- Ensure no carbon particles remain in the filtrate. Refilter if required.
- Collect treated solvent in a clean, labeled container for further distillation or reuse.
5.4 Documentation and Control
- Record:
- Batch number
- Solvent name and volume
- Carbon quantity used
- Contact time
in the “Activated Carbon Usage Log” (Annexure-1).
- Attach CoA copy of activated carbon to batch documentation.
- QC to perform post-treatment testing (color, purity, odor) and release for reuse.
5.5 Disposal
- Used carbon is hazardous waste and must be transferred to EHS-approved bins.
- Dispose through CPCB-approved hazardous waste handlers with manifest records (refer SOP/API/049/2025).
6. Abbreviations
- SOP: Standard Operating Procedure
- QC: Quality Control
- QA: Quality Assurance
- CoA: Certificate of Analysis
- PPE: Personal Protective Equipment
7. Documents
- Activated Carbon Usage Log (Annexure-1)
- CoA of Activated Carbon
- QC Test Report of Treated Solvent
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Subpart D & E
- WHO TRS 957 – Pharmaceutical Waste Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Activated Carbon Usage Log
| Date | Batch No. | Solvent | Volume (L) | Carbon Used (g) | Contact Time (min) | Handled By |
|---|---|---|---|---|---|---|
| 13/04/2025 | API-202504 | Toluene | 150 | 300 | 45 |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | New Recovery Protocol | QA Head |
| 13/04/2025 | 2.0 | Procedure Enhancement and Annexure Added | Compliance Update | QA Head |